Atorvastatin for primary intracerebral hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, randomized, open-label, blinded end-point (PROBE) trial will randomize 264 adults with spontaneous supratentorial intracerebral hemorrhage to best medical treatment (BMT) alone or BMT plus atorvastatin 20 mg once daily for 21 days in a 1:1 ratio. Eligible patients present within 3–24 hours of symptom onset, have a baseline hematoma volume of 5–35 mL and GCS ≥9, and atorvastatin can be started within 48 hours. The primary efficacy endpoint is the proportion of patients with poor functional outcome at 90 days (modified Rankin Scale 4–6), with safety and adverse events monitored throughout follow-up. The trial uses blinded endpoint assessment to limit bias while delivering open-label therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with a diagnosis of spontaneous intracerebral hemorrhage (ICH) confirmed by computed tomography (CT);
* Age 18-80 years;
* Hematoma located in the supratentorial region;
* Time from symptom onset or last known well to baseline CT ranging from 3 to 24 hours;
* Atorvastatin treatment can be initiated within 48 hours of symptom onset or last known well;
* Glasgow Coma Scale (GCS) score ≥9;
* Baseline hematoma volume of 5-35 mL;
* Signed informed consent obtained.

Exclusion Criteria:

* ICH secondary to trauma, tumor, aneurysm, arteriovenous malformation (AVM), vascular anomaly, hemorrhagic transformation of infarction, cerebral venous thrombosis, or anticoagulant-related ICH;
* Patients who have undergone or are scheduled for immediate surgical intervention;
* Pregnancy or lactation;
* Use of oral anticoagulants within 1 month prior to symptom onset;
* Pre-stroke mRS \>1;
* Known allergy to statins, active liver disease, liver dysfunction, or rhabdomyolysis;
* Known terminal illness with a pre-stroke life expectancy of less than three months, or patients with planned withdrawal of care.

Where it's running

• Anqing First People's Hospital of Anhui Province
  Anqing, Anhui, China Recruiting
• Fuyang City Sixth People's Hospital
  Fuyang, Anhui, China Recruiting
• Fuyang Hospital of Anhui Medical University
  Fuyang, Anhui, China Recruiting
• Fuyang People's Hospital
  Fuyang, Anhui, China Recruiting
• Hefei Eighth People's Hospital
  Hefei, Anhui, China Recruiting
• Hefei First People's Hospital
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Qi Li
• Email: qili_md@126.com
• Phone: +8618623511778

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.